Molecular Imaging Exploration of Ocular Angiogenic Activity and Evaluation of Its Interest in the Therapeutic Follow-up of Patients With AMD (Age-related Macular Degeneration) (DMLA-RGD)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: Age Related Macular Degeneration

Treatments: Other: radiopharmaceutical

Study type: Interventional

Funder types: Other

Identifiers

NCT04005443

2019-06

2019-000946-37 (EudraCT Number)

Details and patient eligibility

About

The main objective of this pilot study is to evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the first phase. induction (after 3 months of treatment).

Full description

To date, no functional imaging modality has been validated to assess the level angiogenic activity of choroidal neovascularization in AMD, while the therapeutic use of antiangiogenic agents is almost systematically in the form of intraocular injections.

The therapeutic response is observed anatomically and functionally only after 6 months of treatment. Several arguments in the literature suggest that the therapeutic response occurs earlier at the molecular level, as soon as the induction phase is complete (after 3 months of treatment). The main objective of this pilot study is to evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the first phase. induction (after 3 months of treatment).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18, membership of a social security scheme. Signature of informed consent,
• Subject presenting AMD with unilateral involvement, involving at least 1 Choroidal neovascularization objectified in OCT, naive to any treatment antiangiogenic.
• Initial assessment including at least OCT and measurement of visual acuity, dating from maximum 1 month at the time of PET 68Ga-NODAGA-RGD.

Exclusion criteria

• Pregnant or breastfeeding women, as a result of radiation protection.
• Subjects under 18 years of age and / or not affiliated to a social security scheme.
• Subjects with AMD with bilateral involvement.
• Subjects with AMD without a focus of neovascularization objectified by the classic diagnostic battery.
• Subjects having already been treated with antiangiogenic therapy.
• Subjects with any other ophthalmological pathology. Monophthalmic subjects

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

PET at 68Ga-NODAGA-RGD

Other group

Description:

The first PET scan will be performed within a maximum of one month following the initial ophthalmologic assessment including OCT and measurement of visual acuity (M0);

Treatment:

Other: radiopharmaceutical